Letter sent to Healthcare Professionals: Myalepta (metreleptin) 5.8 mg vial
An inconsistency has been noted in the package leaflet. In Section 7, Step B, the artwork text mentions that 0.6 mL of water for injection (WFI) should be withdrawn from the vial. This is incorrect and could lead to a concentration > 5 mg/mL. The correct volume is 1.1 mL of WFI.
Source:
Amryt Pharmaceuticals
SPS commentary:
Healthcare professionals are advised to point out the inconsistency to patients or to provide the sample letter.